BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEXTANT SPINAL SYSTEM

    MDR report key: 3931542 · Received July 14, 2014

    Report

    Report Number
    1030489-2014-03232
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT "THE ROD WAS DEFECTIVE AND IT WAS IMPOSSIBLE TO INTRODUCE THE ROD INTO THE HEADS OF THE SCREWS, THIS RESULTED IN THE END OF THE PROCEDURE WAS MADE IN OPEN." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409115 SEXTANT SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1